Oral care product and methods of use and manufacture thereof

Abstract

This invention relates to oral care compositions comprising a basic amino acid or salt thereof, and a small particle fraction: and to methods of using and of making these compositions.

The invention claimed is: 
     
       1. An oral care composition comprising a. an effective amount of a basic amino acid in free or salt form; and b. a small particle fraction comprising at least about 5% of the composition by weight, wherein particles of the small particle fraction have a d50 of less than about 5 μm and wherein the small particle fraction comprises precipitated calcium carbonate having d50 of about 0.5 to about 4 μm and silica having d50 of about 1 to about 4 μm. 
     
     
       2. A composition according to  claim 1  further comprising an effective amount of a soluble fluoride salt. 
     
     
       3. A composition according to  claim 1  wherein the basic amino acid is arginine. 
     
     
       4. A composition according to  claim 1  wherein the basic amino acid is partially or wholly in salt form selected from arginine bicarbonate, arginine hydrochloride, arginine phosphate, and combinations thereof. 
     
     
       5. A composition according to  claim 1  comprising arginine bicarbonate. 
     
     
       6. A composition according to  claim 1 , having a radioactive dentin abrasion (RDA) of about 30-about 130. 
     
     
       7. A composition according to  claim 1 , having a radioactive dentin abrasion (RDA) of about 30-about 70. 
     
     
       8. A composition according to  claim 1 , comprising at least about 20% of small particles having a d50 less than about 5 μm. 
     
     
       9. A composition according to  claim 1 , wherein the basic amino acid is arginine bicarbonate and which further comprises sodium monofluorophosphate. 
     
     
       10. A composition according to  claim 1 , further comprising an anionic surfactant. 
     
     
       11. A composition according to  claim 10  wherein the anionic surfactant is sodium lauryl sulfate. 
     
     
       12. A composition according to  claim 1  further comprising an antibacterial agent. 
     
     
       13. A composition according to  claim 12  wherein the antibacterial agent is triclosan. 
     
     
       14. A composition according to  claim 1  further comprising an anionic polymer. 
     
     
       15. A composition according to  claim 14  wherein the anionic polymer is a copolymer of methyl vinyl ether and maleic anhydride. 
     
     
       16. The composition according to  claim 1 , in the form of a toothpaste further comprising one or more of water, abrasives, surfactants, foaming agents, vitamins, polymers, enzymes, humectants, thickeners antimicrobial agents, preservatives, flavorings, colorings and/or combinations thereof. 
     
     
       17. A method comprising applying an effective amount of the oral care composition of  claim 1  to an oral cavity of a subject in need thereof, to reduce or inhibit formation of dental caries; to reduce, repair or inhibit pre-carious lesions of enamel; to reduce or inhibit demineralization and promote remineralization of teeth; to reduce hypersensitivity of teeth; to reduce or inhibit gingivitis; to promote healing of sores or cuts in a mouth; to reduce levels of acid producing bacteria; to increase relative levels of arginolytic bacteria; to inhibit microbial biofilm formation in the oral cavity; to raise and/or maintain plaque pH at levels of at least pH 5.5 following sugar challenge; to reduce plaque accumulation; to treat, reduce, relieve or alleviate dry mouth; to whiten teeth; to reduce erosion; to improve systemic health; to immunize teeth against cariogenic bacteria; and/or to clean teeth and oral cavity. 
     
     
       18. The method of  claim 17  to reduce hypersensitivity of the teeth. 
     
     
       19. An oral care composition comprising a basic amino acid, in free or salt form, and an abrasive material, the abrasive material including a small particle fraction comprising at least about 5 wt % of the total composition weight, wherein particles of the small particle fraction have a d50 of less than 5 μm, and wherein the small particle fraction comprises precipitated calcium carbonate having d50 of about 0.5 to about 4 μm and silica having d50 of about 1 to about 4 μm, for use in the treatment of sensitive teeth within an oral cavity of a subject. 
     
     
       20. An oral care composition according to  claim 19  wherein the basic amino acid is present in an amount of from 0.1 to 20 wt % of the total composition weight. 
     
     
       21. An oral care composition according to  claim 19  wherein the basic amino acid is present in an amount of from 1 to 10 wt % of the total composition weight. 
     
     
       22. An oral care composition according to  claim 19  wherein the basic amino acid comprises arginine. 
     
     
       23. An oral care composition according to  claim 19  further comprising an antibacterial agent in an amount of from 0.01 to 5 wt % of the total composition weight. 
     
     
       24. An oral care composition according to  claim 23  wherein the antibacterial agent is present in an amount of from 0.01 to 1 wt % of the total composition weight. 
     
     
       25. An oral care composition according to  claim 23  wherein the antibacterial agent is triclosan. 
     
     
       26. An oral care composition according to  claim 19  further comprising a soluble fluoride salt in an amount of from 0.01 to 2 wt % of the total composition weight. 
     
     
       27. An oral care composition according to  claim 19  further comprising a source of fluoride ions in an amount to provide 50 to 25,000 ppm by weight of fluoride ions in the total composition weight. 
     
     
       28. An oral care composition according to  claim 26  wherein the soluble fluoride salt is selected from sodium fluoride, sodium monofluorophosphate, and mixtures thereof. 
     
     
       29. An oral care composition according to  claim 19  further comprising an anionic surfactant in an amount of from 0.01 to 10 wt % of the total composition weight. 
     
     
       30. An oral care composition according to  claim 29  wherein the anionic surfactant is present in an amount of from 0.3 to 4.5 wt % of the total composition weight. 
     
     
       31. An oral care composition according to  claim 29  wherein the anionic surfactant is selected from sodium lauryl sulfate, sodium laureth sulfate, and mixtures thereof. 
     
     
       32. An oral care composition according to  claim 19  wherein the small particle fraction comprises at least about 20 wt % of the total composition weight. 
     
     
       33. An oral care composition according to  claim 32  wherein the abrasive material comprises from 15 to 70 wt % of the total composition weight. 
     
     
       34. An oral care composition comprising a basic amino acid, in free or salt form, and a small particle fraction of an abrasive material comprising at least about 5% of the composition by weight, wherein particles of the small particle fraction have a d50 of less than about 5 μm, and wherein the small particle fraction comprises precipitated calcium carbonate having d50 of about 0.5 to about 4 μm and silica having d50 of about 1 to about 4 μm, for enhancing dentinal occlusion within an oral cavity of a subject. 
     
     
       35. An oral care composition according to  claim 34  wherein the basic amino acid comprises arginine and is present in an amount of from 0.1 to 20 wt % of the total composition weight. 
     
     
       36. An oral care composition according to  claim 34  further comprising an antibacterial agent comprising triclosan in an amount of from 0.01 to 5 wt % of the total composition weight. 
     
     
       37. An oral care composition according to  claim 34  further comprising a soluble fluoride salt in an amount of from 0.01 to 2 wt % of the total composition weight. 
     
     
       38. An oral care composition according to  claim 34  further comprising a source of fluoride ions in an amount to provide 50 to 25,000 ppm by weight of fluoride ions in the total composition weight. 
     
     
       39. An oral care composition according to  claim 34  further comprising an anionic surfactant in an amount of from 0.01 to 10 wt % of the total composition weight, the anionic surfactant being selected from sodium lauryl sulfate, sodium laureth sulfate, and mixtures thereof. 
     
     
       40. An oral care composition according to  claim 34  wherein the small particle fraction comprises at least about 20 wt % of the total composition weight. 
     
     
       41. An oral care composition according to  claim 34  wherein the abrasive material comprises from 15 to 70 wt % of the total composition weight. 
     
     
       42. A method of treating sensitive teeth within an oral cavity, the method comprising applying to the oral cavity of a subject the oral care composition of  claim 1  comprising a basic amino acid, in free or salt form, and a small particle fraction comprising at least about 5% of the composition by weight, wherein the particles of the small particle fraction have a d50 of less than about 5 μm, and wherein the small particle fraction comprises precipitated calcium carbonate having d50 of about 0.5 to about 4 μm and silica having d50 of about 1 to about 4 μm, to enhance dentinal occlusion. 
     
     
       43. A composition according to  claim 12 , wherein the antibacterial agent is a zinc salt. 
     
     
       44. A composition according to  claim 43 , wherein the zinc salt is zinc citrate. 
     
     
       45. A composition according to  claim 19  further comprising a zinc salt. 
     
     
       46. A composition according to  claim 45 , wherein the zinc salt is zinc citrate. 
     
     
       47. A composition according to  claim 34  further comprising a zinc salt. 
     
     
       48. A composition according to  claim 47 , wherein the zinc salt is zinc citrate.